Questions and Answers
What agency may intervene in a matter or worker protection even if there are no specific regulations covering the situation?
Occupational Safety and Health Administration
Regulations under the Clean Air Act are administered by which agency?
Environmental Protection Agency
Which agency imposes strict labeling requirements on manufacturers of disinfectants used by Central Service departments?
Environmental Protection Agency
What do healthcare regulations and standards establish?
Signup and view all the answers
Chemical indicators are classified as which type of medical devices?
Signup and view all the answers
Heart valves and pacemakers are examples of what class of FDA medical devices?
Signup and view all the answers
Who is required to report suspected medical device-related deaths to the U.S. Food and Drug Administration?
Signup and view all the answers
Standards and regulations help set levels of ________________________ in our departments.
Signup and view all the answers
Medical device reporting is regulated by which agency?
Signup and view all the answers
What does the Department of Transportation enforce regulations relating to?
Signup and view all the answers
Sometimes state or local regulations differ from federal regulations and when that happens, the most stringent regulations apply.
Signup and view all the answers
It is optional to allow the Occupational Safety and Health Administration's regulation for wearing personal protective equipment in the Central Service decontamination.
Signup and view all the answers
Third-party reprocessors are regulated by the U.S. Food and Drug Administration.
Signup and view all the answers
Recommendations regarding sterilization practices are provided by the Association for the Advancement of Medical Instrumentation.
Signup and view all the answers
The Occupational Safety and Health Administration is a voluntary association dedicated to infection control and prevention.
Signup and view all the answers
Failure to receive accreditation from The Joint Commission can result in the loss of Medicare and Medicaid payments.
Signup and view all the answers
The Society of Gastroenterology Nurses and Associates is a source for information about the proper processing of flexible endoscopes.
Signup and view all the answers
Class III medical devices are identified as high risk.
Signup and view all the answers
Reuse of single-use medical devices is less regulated now than it was in the 1990s.
Signup and view all the answers
The U.S. Food and Drug Administration recalls may be either mandatory or voluntary.
Signup and view all the answers
Study Notes
Regulatory Agencies and Their Roles
- Occupational Safety and Health Administration (OSHA) intervenes in worker protection matters even without specific regulations.
- Environmental Protection Agency (EPA) administers Clean Air Act regulations and enforces strict labeling on disinfectants used in Central Service departments.
Healthcare Regulations and Standards
- Healthcare regulations establish minimal levels of quality and safety for medical practices.
- Standards and regulations are essential for maintaining quality and safety in healthcare departments.
Medical Device Classifications
- Chemical indicators classified as FDA Class II medical devices.
- Heart valves and pacemakers categorized under FDA Class III medical devices, indicating high risk.
Reporting and Compliance
- Device manufacturers and hospitals are mandated to report suspected medical device-related deaths to the U.S. Food and Drug Administration (FDA).
- Third-party reprocessors are regulated by the FDA, ensuring compliance with safety standards.
Accreditation and Impact on Services
- Accreditation from The Joint Commission is crucial, as failure to receive it can lead to loss of Medicare and Medicaid reimbursements.
- Recommendations for sterilization practices are provided by the Association for the Advancement of Medical Instrumentation.
Local vs. Federal Regulations
- When state or local regulations conflict with federal regulations, the most stringent rules apply to ensure higher safety standards.
Personal Protective Equipment (PPE) Regulations
- Compliance with OSHA regulations regarding personal protective equipment in Central Service decontamination is mandatory, not optional.
Medical Device Reporting and Recall
- Medical device reporting is strictly regulated by the FDA; recalls can be either mandatory or voluntary.
Reprocessing and Safety
- Reuse of single-use medical devices is currently more regulated than in the 1990s, responding to safety concerns and practices.
- The Society of Gastroenterology Nurses and Associates provides guidance on the proper processing of flexible endoscopes.
Risk Assessment
- FDA Class III medical devices are identified as high-risk items, requiring stringent regulatory oversight to ensure patient safety.
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
Description
Test your knowledge with these flashcards from Chapter 5 of the IAHCSMM 8th Edition. Focus on key terms and definitions related to central service and safety regulations. Ideal for students and professionals preparing for certification or review in the field.
